Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 8:51 AM
Study NCT ID:
NCT04716595
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2021-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Long Term Study of K-877 Extended Release Tablet
Sponsor:
Kowa Company, Ltd.
Organization:
Study Overview
Official Title:
A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: